Bioprocess Engineering Job at Syngene
Are you ready to elevate your career in biologics and quality control? This exciting Bioprocess Engineering job at Syngene Careers offers a high-impact role as a Biopharma Analyst in Bangalore. It’s a premium opportunity for life science graduates to work with global pharma leaders and gain hands-on experience in biologics testing, regulatory compliance, and cutting-edge analytical techniques.
About the Company
Syngene International Ltd., established in 1993, is a global innovation-focused contract research, development, and manufacturing organization. The company provides integrated scientific services to industries including pharmaceuticals, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals.
With a strong global presence, Syngene collaborates with leading organizations such as Bristol-Myers Squibb, Amgen, GlaxoSmithKline, and Merck KGaA. Its innovation-driven culture is powered by a team of over 4,000 scientists dedicated to solving complex scientific challenges, enhancing R&D productivity, accelerating time-to-market, and reducing the cost of innovation.
Job Details
- Job Title: Biopharma Analyst
- Company: Syngene International Ltd.
- Location: Bangalore, Karnataka, India (Biocon Park)
Job Summary
The Biopharma Analyst is responsible for leading and overseeing daily Quality Control (QC) laboratory operations for biologics. The role involves managing analytical activities, ensuring compliance with regulatory standards, and driving operational excellence in biologics testing.
Roles & Responsibilities
- Leads and manages QC laboratory operations for biologics, including proteins, monoclonal antibodies (mAbs), RNA, and antibody-drug conjugates (ADCs).
- Supervises and mentors a team of analysts, ensuring productivity, training, and high performance.
- Reviews and approves analytical data, Certificates of Analysis (CoAs), and QC documentation.
- Oversees method qualification, validation, transfer, and routine testing using advanced analytical techniques such as HPLC/UPLC, CE, PCR/RT-PCR, ELISA, and bioassays.
- Ensures compliance with ICH guidelines, pharmacopeial standards, and regulatory requirements.
- Manages Quality Management System (QMS) documentation, including investigations related to deviations, incidents, and Out-of-Specification (OOS) results.
- Reviews and approves SOPs, protocols, reports, CAPAs, and investigation records.
- Conducts root-cause analysis and ensures timely closure of quality records.
- Collaborates with cross-functional teams including QA, Manufacturing, MSAT, Regulatory Affairs, and Project Management.
- Supports new project onboarding, client discussions, and regulatory submissions.
- Handles internal, client, and regulatory audits, ensuring continuous audit readiness.
Key Responsibilities
- Manages in-process, finished product, and stability testing in compliance with regulatory norms.
- Ensures proper handling and maintenance of QMS documentation.
- Maintains continuous audit preparedness.
- Provides guidance to analysts on laboratory practices and analytical procedures.
Qualifications
Master’s degree (M.Sc./M.Tech) in Biotechnology or Bioprocess Engineering.
Technical & Functional Skills
- Strong expertise in analytical techniques for large-molecule characterization and testing.
- In-depth knowledge of biologics testing and method lifecycle management.
- Experience working in GMP-regulated environments.
- Strong understanding of regulatory guidelines related to biologics.
- Ability to manage multiple projects and meet tight timelines.
- Excellent problem-solving skills, particularly in investigations and CAPA management.
Behavioral Competencies
- Demonstrates assertiveness and a results-driven approach to task completion.
- Exhibits strong influencing and leadership skills.
- Capable of addressing complex challenges with effective solutions.
